This document outlines stability testing conditions for pharmaceutical products in different climatic zones. It divides the world into five zones based on average temperature and relative humidity: Zone I (Temperate), Zone II (Subtropical/Mediterranean), Zone III (Hot/Dry), Zone IVa (Hot/Humid Tropical), and Zone IVb (Hot/Very Humid). It provides the target temperature and humidity levels for long term testing in each zone lasting a minimum of 12 months. It also lists accelerated and intermediate testing conditions involving higher temperatures and shorter durations of 6 months. Finally, it lists the countries assigned to each climatic zone.

1. Stability studies
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2. Zone Major countries Temp (± 2°C) RH (± 5%RH)
I. Temperate US, UK, Russia, North Europe 21°C 45%
II. Subtropical/Mediterranean South Europe, Japan 25°C 60%
III. Hot/Dry India , Iraq 30°C 35%
IVa. Hot/humid / tropical zone Iran, Egypt 30°C 70%
IVb. Hot/very humid (ASEAN testing condition) Brazil, Singapore 30°C 75%
Refrigerated - 5°C± 3°C No humidity
Frozen - -15°C± 5°C No humidity
Long term testing condition
Zone Temperature (± 2°C) RH (± 5%RH) Minimum duration
I. Temperate 21°C 45% 12 months
II. Subtropical/Mediterranean 25°C 60% 12 months
III. Hot/Dry 30°C 35% 12 months
IVa. Hot/humid / tropical zone 30°C 70% 12 months
IVb. Hot/very humid (ASEAN testing condition) 30°C 75% 12 months
Refrigerated 5°C± 3°C No humidity 12 months
Frozen -15°C± 5°C No humidity 12 months
Accelerated & Intermediate testing condition
Zone Temperature (± 2°C) RH (± 5%RH) Minimum duration
Accelerated Ambient 40°C ± 2°C 75%± 5% RH 6 months
Accelerated Refrigerated 25°C± 2°C 60%± 5% RH 6 months
Accelerated frozen 5°C ± 2°C No Humidity 6 months
Intermediate 30°C± 2°C 65%± 5% RH 6 months

3. Climatic zones  Zone-I Zone-II Zone-III Zone-IVa Zone-IVb
European All countries -
American Chile, Canada & US
Barbados, Belize, Brazil, Costa Rica, Dominican
Republic, Ecuador, El Salvador, Guatemala,
Guyana, Haita, Honduras, Jamaica, Columbia,
Cuba, Nicaragua, Dutch Antilles, Panama,
Paraguay, Puerto Rico, Venezuela. All of these
countries are assigned to CZ IV.
Asia
Afghanistan, Armenia,
Azerbaijan, China, Georgia,
Iran, Israel, Japan, Kazakstan,
Kirghizia, Korea, Lebanon,
Nepal, Syria, Tadzhikistan,
Turkey, Turkmenia,
Uzbekistan
Bahrain, Bangladesh, Hong Kong, India,
Indonesia, Iraq (III), Jordan (III), Kampuchea,
Qatar, Kuwait, Laos, Malaysia, Maldive Islands,
Myanmar, Oman, Pakistan, Philippines, Saudi
Arabia, Singapore, Sri Lanka, Taiwan,
Thailand, United Arab Emirates, Vietnam,
Yemen
African
Egypt, Algeria, Tunesia, Libya,
Morocco, Namibia, Ruanda,
South Africa, Tunesia, Zambia,
Zimbabwe.
Angola, Ethiopia, Benin, Botswana (III),
Burkino Faso, Burundi, Djibouti, Ivory Coast,
Gabon, Gambia, Ghana, Guinea, Cameroon,
Kenya, Longo, Liberia, Madagascar, Malawi,
Mali, Mauritania, Mozambique, Niger, Nigeria,
Senegal, Sierra Leone, Somalia, Sudan,
Tanzania, Togo, Chad (III), Uganda, Zaire,
Central African Republic.
Australia/Oceanic Australia, Newszealand Figi. Society Islands, Marshall Islands, New
Caledonia, Papua-New Guinea, Samoa, Tonga.